- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04570826
A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS
EFFECTS OF A MEDITATION PROGRAM ON THE QUALITY OF LIFE IN HIGH-BURDEN INFORMAL CAREGIVERS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A non-randomized repeated-measures controlled clinical trial was conducted with convenience allocation of participants into intervention (n = 18) or control group (n = 17). Due to ethical reasons, it was not possible to randomize the patients.
The investigators invited from different associations in Granada city and its province through word and mouth or by telephone to 45 volunteer informal caregivers. 40 of them enrolled in this study but only 37 finalized the program, 24.3% male and 75.7% female with a mean (SD) age of 44.03 (7.30) years. The people that have previous experience in mind body practices or cardiovascular diseases were excluded. All the caregivers received information about the study and informed consent was obtained from all participants. This study was approved by the CEI-GR (C-9) ethics committee and followed the principles of the Declaration of Helsinki. Convenience sampling was used to assign caregivers to the control or experimental groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Granada, Spain, 18016
- Lourdes Díaz Rodríguez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People who care for a dependent family member or close relative and live with him/her in the same home for at least two years with a caregiver burden of more than 55 points in Zarit Burden Scale.
Exclusion Criteria:
- People that have previous experience in mind body practices or cardiovascular diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Meditation program
The experimental group participated in the Meditation program during one month, eight sessions with a total of sixteen hours.
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The caregivers received eight sessions lasting each one two hours with the following sequence: before each practical exercises they always received 15 minutes about scientific theoretical evidence explaining the importance of doing them: to get a comfortable posture they received 25 minutes of mobility, flexibility, balance, strength and endurance exercises.
To increase lung capacity, 25 minutes of costal, diaphragmatic and clavicular breathing exercises.
Finally, to have an open attitude without distractions or judging they practiced 25 minutes of body awareness exercise observing sensations, thoughts and perceptions with gratitude and compassion.
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Active Comparator: Scientific descriptions about meditation
The control group received scientific descriptions about meditation.
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The control group received scientific descriptions about meditation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Happiness on the Lima happiness questionnaire after 1 month
Time Frame: Baseline and after 1 month
|
Lima happiness questionnaire: Validated self-administered questionnaire consisting of 27 items, integrated into 4 subscales (Positive sense of life, Satisfaction with life, Personal fulfillment and Joy of life), which refer to the level of happiness or satisfaction that the person has with respect to his life. The respondent may be: (1) Strongly agree, (2) Agree, (3) Neither agree nor disagree, (4) Disagree or (5) Strongly disagree, with any question that arises. According to the total score there are 5 levels of happiness: from 27-87: very low happiness, 88-95: low, 96-110: medium, 111-118: high, 119-135: very high. |
Baseline and after 1 month
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Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) after 1 month
Time Frame: Baseline and after 1 month
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Validated self-administered instrument for outpatients that advises on the possible presence of anxiety and depression in any non-psychiatric medical consultation. Describe how the patient feels affective and emotionally during the last week. It has 14 items, 7 for each subscale with a scale similar to four points (from 0 to 3). Lower scores reflect better outcomes. |
Baseline and after 1 month
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Change from Baseline in Heart rate and Heart rate variability after 1 month
Time Frame: Baseline and after 1 month
|
We measured short-term HRV using an accepted method in order to assess the cardiovascular balance (Kappussami 2020).
We asked participants to lie in a supine position for 10 min of rest with normal breathing (following a metronome at 0.2 Hz) and no external stimulation in a quiet room with a temperature of 22-25 °C.
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Baseline and after 1 month
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Change from Baseline in Blood pressure/heart rate after 1 month
Time Frame: Baseline and after 1 month
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We measured blood pressure and heart rate before and after the treatment session using an Omron HEM-7320-Z validated automatic oscillometer.
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Baseline and after 1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Interventional (Oncolys BioPharma Inc)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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